Cleared Special

K070268 - SIGNATURE EDITION INFUSION SYSTEM

K070268 is an FDA 510(k) clearance for SIGNATURE EDITION INFUSION SYSTEM, manufactured by Cardinal Health 303,Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 25-day FDA review.

K070268 · Cardinal Health 303,Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
25d
Days
Class 2
Risk

K070268 is an FDA 510(k) clearance for the SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardinal Health 303,Inc. (San Diego, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health 303,Inc. devices

FDA 510(k) Submission Details - K070268

510(k) Number K070268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date February 23, 2007
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 460
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K070268.
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K062699 · B.Braun Medical, Inc. · Oct 2006